Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
16763969 double 11166970
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-4 in the reply filed on 03/19/2024 is acknowledged.
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/19/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art.
All the factors have been considered with regard to the claims, with the most relevant factors discussed below:
The specification is not enabling for preventing ADHD. The only established prophylactics are vaccines not the small molecule compound such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the disease occurs.
According to the instant specification, the term “prevention” as used herein refers to any action of suppressing or delaying diseases by administering the composition according to the present disclosure. Hence, "preventing" refers to the prophylactic treatment of a subject in need thereof. This would require extensive and potentially open-ended clinical research on healthy subjects having or susceptible the recited disease states. There is no working example of such a preventive procedure in man or animal in the specification. The working examples present are in animal models with ADHD. Applicant is encouraged to provide data or citations for preventing reperfusion injury with reversible succinate dehydrogenase inhibitors. The claims rejected are drawn to clinical use of medicine and are therefore physiological in nature. The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted with the disease before the fact. The artisan using Applicants invention would be a Board Certified physician in treating diseases with an MD degree and several years of experience. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case.
Suggestion: DELETE claim language for ‘preventing’
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18684828 (reference application), further in view of Dhar, J.Med.Chem. 1994,37, 2334-2342; Abdullah, Combinatorial Chemistry & High Throughput Screening (2020), 23(9), 836-841; Edden, Arch Gen Psychiatry. 2012 July ; 69(7): 750–753 and Kim, Exp Neurobiol 2017; 26(3): 122-131. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
The difference is in the active ingredients in the claimed method in conflicting claims is different. Note that both are previously known compounds.
These compounds are GABAergic (see below). The inherent property of the active ingredients namely reuptake inhibition. Under normal conditions, GATs (primarily GAT1 and GAT3) rapidly clear GABA from the extracellular space to terminate inhibitory signals. Blocking them causes an immediate accumulation of ambient GABA.
The instant active ingredient SNAP-5114 is previously known for GABA Uptake inhibition as taught by Dhar, J.Med.Chem. 1994,37, 2334-2342 at page 2335 Figure 1.
The 18684828 active ingredient is Tisolagiline is increases as GABA levels indirectly.
Edden teaching concludes that GABA concentration in ADHD is concordant with recently reported deficits in short intracortical inhibition in ADHD and suggests a GABAergic deficit in ADHD. that Reduced GABA Concentration in Attention-Deficit/Hyperactivity Disorder. Kim also teaches the GABA and ADHD are linked inexorably.
Taken together, the teachings of Edden and Kim suggests compounds with the inherent biochemical property of (increasing GABA levels, by reuptake inhibition) for the treatment of ADHD.
Also compare sections under Advantage Effects
of instant specification page 4 opening statement and
of conflicting case specification page 3, opening statement.
Note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dhar, J.Med.Chem. 1994,37, 2334-2342; Lee US20150290181; Edden, Arch Gen Psychiatry. 2012 July ; 69(7): 750–753 and Kim, Exp Neurobiol 2017; 26(3): 122-131..
Dhar teaches the active ingredient of the claims as GABA Uptake Inhibitors. Lee also teaches instant compound SNAP5114 in claims as inhibitors of GABA transport.
Suggestions that GABA Uptake Inhibitors could be useful for treating ADHD are found in the teachings of Edden and Kim. According to Edden teaching concludes that GABA concentration in ADHD is concordant with recently reported deficits in short intracortical inhibition in ADHD and suggests a GABAergic deficit in ADHD. that Reduced GABA Concentration in Attention-Deficit/Hyperactivity Disorder. Kim also teaches the GABA and ADHD are linked inexorably.
Taken together, one of skill in the art would have reasonable expectation of success in using the inherent biochemical property of the instant compound as taught by Dhar for treatment of ADHD. Hyperactivity is one of three recognized ADHD presentations, corresponds to claim 3; Lee pharmaceutical composition of claims read on the instant claim 4.
The art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mamiya, Precision Medicine Care in ADHD: The Case for Neural Excitation and Inhibition, Brain Sci. 2021, 11, 91, 1-12.
Dalby, GABA-level increasing and anticonvulsant effects of three different
GABA uptake inhibitors. Neuropharmacology 39 (2000) 2399–2407.
Kim, 11166970 claims to treating attention deficit hyperactivity disorder (ADHD) or autism in a subject in need thereof, comprising administering a composition comprising therapeutically effective amounts of aucubin or a pharmaceutically acceptable salt thereof to treat ADHD or autism.
Objection:
Claim 2 is drawn to the same active ingredient in claim 1.
SNAP5114 of claim 1 and the pictured compound in claim 2 are one and the same. As such the language ‘is a compound represented by’ in claim 2 raises the question if is there a SNAP5114 that is different from the one pictured in claim 2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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